Safety And Efficacy Analysis Of Troxerutin Brain Protein Hydrolyzate For Occupational Chronic Lead Poisoning

Background and AimsOccupational chronic lead poisoning,a systemic disease,mainly involving the nervous system, the hematopoietic system and digestive system, is the top one statutory reporting occupational chronic diseases. Lead colic or lead encephalopathy can occur in severe patients. To explore effective and safe methods for the prevention and treatment of Occupational chronic lead poisoning has been a subject of widespread attention at home and abroad. But there is still a lack of more effective treatment methods, and the existing treatment options include removing lead and symptomatic treatment, such as sodium edetate calcium and vitamins. Troxerutin brain protein hydrolyzate has precise efficacy in the treatment of various cerebrovascular diseases, but there is still no study about safety and efficacy analysis of troxerutin brain protein hydrolyzate for occupational chronic lead poisoning, so we designed this study. Methods72 confirmed occupational chronic lead poisoning patients in our hospital were enrolled from November 2004 to April 2013. These paitents were randomly divided into 2 groups according to the extent of lead poisoning:one group was administered troxerutin brain protein hydrolyzate on the basis of the standard intravenous therapy(experimental group) and the other group received only standard care(control group). The following variables were assessed before and after the treatment: motor nerve conduction velocity(MNCV), the end of the incubation period, sensory nerve conduction velocity(SNCV) and the end of the incubation period by EMG; neurobehavioral function tests with UPDRS scale, MMSE scale and HAMD scale; serum Pb B、urinary Pb B、serum ZPP、serum EP,urinary ALA and adverse reactions. ResultsEach group has 36 patients with between comparable gender, age and severity. The most common signs and symptoms in the experimental group were as follows: 35(97.2%) tendon reflexes, 31(86.1%) fatigue, 25(69.4%) anorexia, 22(61.1%) depression, 19(52.8%) numbness of the limbs, 19(52.8%) headache/dizziness, etc; the average concentrations of serum Pb B、urinary Pb B、serum ZPP、serum EP,urinary ALA was as follows: 687.49μg/L,195.65μg/L, 18.5μg/g Hb、4.56μmol/L 和 72.5μmol/L;the average MNCV of median nerve, ulnar nerve and peroneal nerve were 54.9M / S, 56.7M / S and 47.2 M / S, respectively; the end of the incubation period averaged 3.6MS, 3.3 MS and 2.2MS respectively; the average SNCV of median nerve, ulnar nerve and peroneal nerve were 55.7 M/S,56.0M/S and 49.5M/S,respectively; the end of the incubation period averaged 2.3MS,2.7MS and 2.9MS, respectively; the UPDRS score, HAMD score and MMSE scores were averaged 35(28-68),21(16-27)and 9(6-15);the main ECG abnormality changes were sinus arrhythmia(19.4%), sinus bradycardia(16.7%), low voltage(13.9%), ventricular contractions(11.1%) and so on; the proportion of patients with abnormal blood pressure in <30 age group, 30-40 age group, 40-50 age group,> 50 age group were 1/5(5%), 3/8(37.5%), 3/10(30%) and 5/13(38.5%).The most common signs and symptoms in the experimental group were as follows: 32(88.9%) tendon reflexes, 33(91.6%) fatigue, 31(86.1%) anorexia, 16(44.4%) depression, 23(63.8%) numbness of the limbs, 21(58.3%) headache/dizziness, etc; the average concentrations of serum Pb B、urinary Pb B、serum ZPP、serum EP,urinary ALA was as follows: 725.11μg/L、215.11μg/L、17.8μg/g Hb、4.90μmol/L and 69.4μmol/L;the average MNCV of median nerve, ulnar nerve and peroneal nerve were 58.8M/S,62.6 M/S and 56.7M/S respectively; the end of the incubation period averaged 2.9MS,2.3MS and 3.6MS, respectively; the average SNCV of median nerve, ulnar nerve and peroneal nerve were 61.7M/S,56.9M/S and 62M/S,respectively; the end of the incubation period averaged 1.6MS,2.1MS and 2.5MS, respectively;the UPDRS score, HAMD score and MMSE scores were averaged 33(25-59),19(14-26),and 8(7-16);the main ECG abnormality changes were sinus arrhythmia(13.9%), sinus bradycardia(22.2%), low voltage(11.1%) and so on; the proportion of patients with abnormal blood pressure in <30 age group, 30-40 age group, 40-50 age group,> 50 age group were 0/4(0%),2/9(22.2%),4/11(36.4%)and 4/12(33.3%), respectively. No difference was observed between the two groups for above variables.After troxerutin brain protein hydrolyzate theray, headache/dizziness(13.9% vs. 30.6%), fatigue(25% vs. 36.1%) and sleep disorders(8.3% vs. 25%) in the experimental group were significantly improved when compared with control group; SNCV test in the experimental group was obviously faster than the control group [median nerve: 68.8 M / S vs 59.7 M/S, the ulnar nerve:. 72.6 M/S vs 65.1 M/S, the common peroneal nerve:. 66.7 M/S vs. 59.4 M/S]; the end of the incubation period for the motor nerve in the experimental group was significantly shorter than of the control group [median nerve 2.5MS vs 3.9 MS, ulnar nerve 1.9 MS vs 2.3 MS and peroneal nerve 2.2MS vs 3.3MS]; SNCV test in the experimental group was obviously faster than the control group [median nerve: 72.5M/S vs 62.8M/S, the ulnar nerve: 65.8M/S vs 58.1 M/S, the common peroneal nerve:. 71.9 M/S vs. 63.4 M/S]; the end of the incubation period for the motor nerve in the experimental group the experimental group was significantly shorter than the incubation period of the control group [median nerve 2.5MS vs 2.1MS, ulnar nerve 3.2 MS vs 2.7 MS and peroneal nerve 3.4MS vs 2.8MS]; the UPDRS score(16 vs 21), HAMD score(16 vs 17) in the experimental group was significantly lower than the control group; while MMSE score was significantly higher in the experimental group(12 vs 9). In addition, no differences were observed for serum Pb B、urinary Pb B、serum ZPP、serum EP,urinary ALA between the two groups; abnormal ECG and abnormal blood pressure were also not statistically significant between the two groups. Finally, no adverse reactions were observed for troxerutin brain protein hydrolyzate except mild headaches, dizziness, skin allergy symptoms. ConclusionsHeadache, dizziness, fatigue, and sleep disorders were significantly improved in patients with chronic occupational lead poisoning after troxerutin brain protein hydrolyzate therapy; MNCV and SNCV were improve with the shorten of the end of the incubation period;After treatment, UPDRS score, HAMD score was significantly reduced and MMSE score was significantly increased。Notably, no differences were observed for serum Pb B、urinary Pb B、serum ZPP、serum EP,urinary ALA, abnormal ECG, abnormal blood pressure. Troxerutin brain protein hydrolyzate is safe and feasible for occupational chronic lead poisoning, and related adverse reactions were not increased.